Electronic product compliance
Manufacturers of hearing aids and audiological equipment, hearing healthcare providers and operators of hearing clinics must address regulatory requirements and technical standards. These requirements arise when hearing aids are prepared for market introduction, when audiological equipment is tested according to applicable national and international standards, or when hearing clinics in Denmark seek approval to dispense hearing aids with public subsidy.
Without specialised technical knowledge, equipment and testing facilities, documenting these technical characteristics can delay the preparation of technical documentation and hearing clinic approval processes. Our Technical Audiology Laboratory has approved more than 300 Danish hearing clinics and provides specialised measurements, audiological testing and sound quality evaluations. We also participate in international standardisation work. The service is part of our catalogue within electronic product compliance.
Challenges
Hearing aid manufacturers must document acoustic performance, electromagnetic compatibility, product safety, and reliability in accordance with applicable standards. When measurements or test documentation are incomplete, organisations may encounter delays in preparing technical documentation required for product introduction.
Hearing clinic approval requirements are not fulfilled
Private hearing clinics must meet national requirements for audiometric equipment, room conditions, and operational procedures to obtain approval as providers of hearing aid services. If testing of audiometers or background noise measurement in audiometric rooms is incomplete, clinics may not obtain approval to dispense hearing aids with public subsidies.
Audiological equipment performance is not documented
Manufacturers of audiological equipment must demonstrate that instruments meet electroacoustic, electromagnetic compatibility and safety specifications. Without documented measurements, organisations may lack the technical basis required to evaluate equipment characteristics or prepare regulatory documentation.
Benefits
Accredited hearing aid testing
Acoustic performance testing, electromagnetic compatibility testing and reliability assessments document the electroacoustic characteristics of hearing aids according to applicable standards.
Test reports provide the measurements manufacturers use when preparing technical documentation for hearing aid products.
Hearing clinic approval
Testing of audiometers and measurement of background noise in audiometric rooms are part of the approval process for private hearing aid providers. The Technical Audiology Laboratory is designated to approve private providers of hearing aid services in Denmark.
Audiological equipment testing
Electroacoustic, EMC, product safety, and reliability testing provide documented test results that describe the electroacoustic characteristics of audiological equipment. These measurements support the technical evaluation of audiometers and related instruments.
Research and training in technical audiology
Investigations, psychoacoustic studies and training activities address specialised topics within technical audiology. These activities support manufacturers, healthcare organisations and universities working with hearing technology and audiological equipment.
Contact our technical audiology team to define appropriate test plans for your hearing aids or audiological instruments or for an appointment regarding the approval of a hearing clinic.
Service scope
Acoustic performance testing, electromagnetic compatibility testing, and reliability assessments are conducted in accordance with relevant standards for hearing aid products. Measurements document the electroacoustic characteristics and operational performance of hearing aids.
We also provide testing of medical devices.
Standards
FAQ
Reach out to Søren Ludvig Jørgensen for more information.
